Feasibility Study Phase C: Expansion Into Multiple Institutions for Training in the Use of the LUM Imaging System for Intraoperative Detection of Residual Cancer in the Tumor Bed of Female Subjects With Breast Cancer
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 234
- 试验地点
- 32
- 主要终点
- Collect Data to Refine and Verify the Tumor Detection Algorithm.
研究概览
简要总结
This is a non-randomized, open-label, multi-site study to collect safety and efficacy data on an intraoperative imaging system, the LUM Imaging System (LUM015 imaging agent in conjunction with the LUM imaging device), in identifying residual cancer in the tumor bed of female breast cancer patients. During the study, study physicians and clinical staff will complete hands-on training in anticipation of the upcoming pivotal study. Site-specific or user-specific issues related to the use of the device will be identified and addressed. Additionally, the data collected in the study will be used to continue training the tumor detection algorithm of the device.
In this study, patients will be injected with LUM015 prior to surgery. The study physicians will perform lumpectomy procedures according to his or her institution's standard of care practice. After the main specimen removal is completed, the study physician will use the LUM Imaging Device to image the tumor bed. Therapeutic shaves will be removed based on the recommendation of the LUM Imaging System. Patients will be followed until their first standard of care post-operative follow-up visit.
详细描述
For breast cancer lumpectomies, the presence of residual cancer cells left in the tumor bed after initial resection in inferred by post-operative margin assessment of the resected tissue by a pathologist.
Phase C enrollment will include approximately 5 patients per surgeon, with 2-3 surgeons per site and up to 20 sites. Subjects undergoing a lumpectomy procedure to treat primary breast cancer will be injected with a single dose of LUM015 4 ± 2 hours prior to surgery at a dose of 1.0 mg/kg. The sequence of events during the surgical procedure will vary based on the standard of care used by the surgeon. Patients will receive at a minimum the standard of care practices for each site. Lumicell-guided shaved cavity margins will be removed after the surgeon has attempted to remove the main specimen with grossly negative margins.
Study treatment ends when the surgery is completed. All patients will continue their enrollment in the study until their first follow-up visit and they will continue to be followed until the medical team determines no further surgical intervention is required. Patients with adverse events that are determined to be possibly related to the LUM Imaging System will be followed until resolution or stabilization of the adverse event.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Collect Data to Refine and Verify the Tumor Detection Algorithm.
时间窗: 1 day
Data were collected from mITT population, which included all the patients imaged with the LUM Imaging System. This metric measured the residual cancer that current Standard of Care (SOC) lumpectomy failed to remove. It was defined as among all the patients, the percentage of subjects who had residual cancer found in at least one LUM-guided shave (therapeutic shave or "T-shave") after the current initial SOC lumpectomy procedure was completed.
次要结局
- Detection and Conversion of Positive Margins in Subjects After BCS SOC(1 Week)
- Tumor Removal Rate Within Subjects Having Positive Standard of Care Margins(1 Week)
- Tumor Removal Rate Within Subjects Having All Negative SOC Margins(1 Week)
- Number of Patients With Reported Adverse Events(Patients were evaluated for adverse events from time of injection until standard post-surgery follow-up visit (Median 31 days after lumpectomy).)
- Tumor Removal Rate in the Whole mITT Population by SOC Margin Status(1 week)
- Volume of Therapeutic Shaves Removed During Lumpectomy.(1 Week)
- Contribution of Therapeutic Shaves to Total Volume Removed During Lumpectomy.(1 Week)
- Sensitivity and Specificity of the LUM Imaging System in Predicting Residual Cancer in the Cavity(1 Week)